A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

Conditions

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Pegozafermin — BIOLOGICAL
  Subcutaneous injection
• Placebo — DRUG
  Subcutaneous injection

Study Details

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).

Key Dates

Start date

May 24, 2024

Status verified

Jun 2026

Primary completion

Jun 30, 2028

Completion

Aug 31, 2031

Study Design

Enrollment

762 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pegozafermin
• Placebo Comparator: Placebo
  Matched placebo

Primary Outcome Measure

Proportion of Participants Achieving Fibrosis Regression [ Time Frame: Baseline through Month 24 ]

Central Contacts

• ENLIGHTEN clinical trial
  1-415-432-9270
  [email protected]

Locations (135)

Find similar trials in Birmingham, AL

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